IN10018+ Standard Chemotherapy (+KN046) in Subjects With Advanced Pancreatic Cancer
A Phase Ib/II, Open-label Clinical Study to Evaluate the Safety, Tolerability and Antitumor Activities of IN10018+Standard Chemotherapy and IN10018+Standard Chemotherapy+KN046 in Subjects With Advanced Pancreatic Cancer
InxMed (Shanghai) Co., Ltd.
70 participants
Dec 8, 2022
INTERVENTIONAL
Conditions
Summary
This study is a multicenter, open-label, single-arm, phase Ib/II clinical study comprising two phases: dose confirmation phase and dose expansion phase. The objective of the dose confirmation phase is to determine the recommended Phase II dose (RP2D) of IN10018+ standard chemotherapy (albumin-bound paclitaxel + gemcitabine) and IN10018 + KN046 + standard chemotherapy in subjects with advanced pancreatic cancer. The dose expansion phase will further explore the antitumor activities and safety of combination therapy in subjects with advanced pancreatic cancer.
Eligibility
Plain Language Summary
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Interventions
IN10018 orally once daily at approximately the same time each day, to ensure a dosing interval of approximately 24 hours.
Albumin-bound paclitaxel will be administered as per the schedule specified in the respective arm.
Gemcitabine will be administered as per the schedule specified in the respective arm.
KN046 5 mg/kg on Day 1 of each 21-Day Cycle.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05827796